NEW DELHI: Days after the Centre approved a formula for determination of compensation, a group of patients affected by Johnson and Johnson's faulty hip implants on Thursday told the government that the method was unacceptable to them as it was done "without due consultations" with stakeholders and "unjustly" denies relief to many of them. In a letter to Union health minister J P Nadda, the patients alleged that the formula devised by the ministry has "multiple gaps" and is "riddled with ambiguities". The patients said it will be "necessary" to hear their views in order to arrive at a compensation formula which is "just and fair" to the affected. The letter said that despite their repeated appeals that transparency in the proceedings of the committees entrusted to carry out the compensation and in the implementation of the mechanism is paramount, patients are being completely sidelined and reduced to mere spectators even in the government-led process. "We respectfully submit that we cannot accept a formula that was devised through discussions exclusively with Johnson and Johnson, and without a consultative process with all the stakeholders, as has been incorrectly represented in the media. "The formula therefore has multiple gaps that may have easily been avoided if the process of consultation with victims and civil society groups was done. The formula unjustly denies compensation to many patients," Vijay Vojhala, one of the 70 affected patients who have come together under the banner Hip Implant Patients Support Group , said in the letter. The group claims that its members are patients from across India who have been implanted with faulty hip implants such as DePuy or Johnson and Johnson's ASR resurfacing and ASR XL implants. The group comprises patients, family members and some public health specialists advocating for regulatory reforms to improve patient safety. The health ministry recently approved the formula for determination of compensation for patients who prior to August 2010, had received faulty articular surface replacement hip implants manufactured by the Johnson and Johnson. According to the formula, those affected were eligible for compensation ranging from Rs 30 lakh to Rs 1.2 crore. The government had constituted a central expert committee under the Chairmanship of Dr RK Arya, Director, Sports Injury Centre, to determine the quantum of compensation. The central expert committee after holding five meetings prepared a formula for determining compensation for the ASR victim patients, which has been approved by the ministry However, the patients asked if the formula account for the specificity of patients' circumstances like cases of multiple faulty implants and medical histories. "Its poor formulation renders it incomplete and riddled with ambiguities. Any process relying on this formula will not be able to deliver just and fair compensation to patients and their families, defeating the purpose of the exercise," the letter said. The affected patients had written to Nadda on October 15 and again on October 20 this year to express serious concerns regarding the lack of transparency and exclusion of patients in the compensation process but had received no response, the letter said. "We are disturbed that government officials have given statements to the media to project that the formula was derived through a consultative process and that all stakeholders accepted it ..." "We would like to clarify that in spite of repeated requests, to date not a single consultation has taken place regarding the compensation process or the formula for determining the quantum of compensation with affected patients or civil society groups," the letter said. They said after studying the proposed formula, numerous doubts and questions have arisen. In addition, the patients are able to identify various shortcomings in the formula as well as limitations in its applicability, they said.

Medical management, which is critically important to patients, is being ignored even though it is very much part of the recommendations put forth by the Expert Committee report and the terms of reference of the Central Expert Committee that is working on compensation, they said. "We therefore request that looking at the seriousness of the issues involved, it will be necessary to hear our views in order to arrive at a compensation formula which is just and fair to patients. We will appreciate if advance notice is given to us to enable our group members to attend the meeting," the letter said.